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Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain

Primary Purpose

Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
muscle layer fixation of thoracic drainage tube
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring chest tube drainage, thoracic drainage, thoracoscopic surgery, Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18<age<80;
  • ASA≤III
  • Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered.
  • Normal cardiopulmonary function [predicted forced expiratory volume in the first second(FEV1%) >50% and ejection fraction (EF) >50%of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg;

Exclusion Criteria:

  • History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion;
  • Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension(PaCO2) >50 mmHg];
  • Significant cardiac history.

Sites / Locations

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

muscle layer fixation group

conventional skin fixation group

Arm Description

Outcomes

Primary Outcome Measures

Postoperative Pain
The postoperative pain is assessed using a Visual Analog Scale (VAS)
Pain-associated inflammatory factor
the level of pain-associated inflammatory factor in blood, including CRP, PCT, IL6 and TNFa
Dosage of analgesics
Dosage of analgesics

Secondary Outcome Measures

Full Information

First Posted
January 9, 2022
Last Updated
January 22, 2022
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05202249
Brief Title
Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain
Official Title
Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain in Patients Undergoing Uniport Thoracoscopic Pulmonary Resection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. The investigators aimed to determine whether a muscle layer fixation of thoracic drainage tube could release postoperative pain in patients with uniport thoracoscopic pulmonary resection compared with conventional skin fixation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm, Postoperative Pain, Thoracoscopic Surgery
Keywords
chest tube drainage, thoracic drainage, thoracoscopic surgery, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
muscle layer fixation group
Arm Type
Experimental
Arm Title
conventional skin fixation group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
muscle layer fixation of thoracic drainage tube
Intervention Description
The thoracic drainage tube is fixed on the muscle layer of the uniport
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
The postoperative pain is assessed using a Visual Analog Scale (VAS)
Time Frame
From date of operation until the date of chest tube removal, assessed up to 7 days
Title
Pain-associated inflammatory factor
Description
the level of pain-associated inflammatory factor in blood, including CRP, PCT, IL6 and TNFa
Time Frame
the first day after surgery
Title
Dosage of analgesics
Description
Dosage of analgesics
Time Frame
From date of operation until the date of chest tube removal, assessed up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18<age<80; ASA≤III Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered. Normal cardiopulmonary function [predicted forced expiratory volume in the first second(FEV1%) >50% and ejection fraction (EF) >50%of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg; Exclusion Criteria: History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension(PaCO2) >50 mmHg]; Significant cardiac history.
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Li, MD
Phone
+8615023072303
Ext
023-68757983
Email
soloonline1981@163.com
First Name & Middle Initial & Last Name & Degree
Kejie Huang, Bachelor
Phone
+8615123978947
Ext
023-68757982
Email
hkj941118@outlook.com

12. IPD Sharing Statement

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Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain

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